Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Guidance for Industry and Food and Drug Administration Staff; Availability, 11207 [2013-03487]

Download as PDF Federal Register / Vol. 78, No. 32 / Friday, February 15, 2013 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0395] Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation.’’ This guidance provides FDA’s recommendations on clinical trial designs for surgical ablation devices intended for the treatment of atrial fibrillation. SUMMARY: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation’’ to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847– 8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Libet Garber, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1254, Silver Spring, MD 20993–0002, 301–796–6912. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES DATES: I. Background Atrial fibrillation (AF) is a complex arrhythmia of the heart. This guidance VerDate Mar<15>2010 19:09 Feb 14, 2013 Jkt 229001 describes elements of suggested clinical study design for surgical ablation devices used to treat patients with longstanding persistent AF and patients with symptomatic paroxysmal AF, such as inclusion and exclusion criteria and assessment of effectiveness, which may differ for these patient populations. In the Federal Register of September 14, 2009 (74 FR 46996), FDA announced the availability of the draft guidance document. Interested persons were invited to comment by December 14, 2009. Three sets of comments were received with recommendations related to definitions and certain elements of the recommended study design(s), such as study endpoints, endpoint assessments, appropriate control groups, and followup of study subjects. In response, FDA revised the guidance document to address the comments and clarify our recommendations as appropriate. This guidance supersedes the draft guidance entitled ‘‘Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation,’’ dated September 14, 2009. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on clinical study designs for surgical ablation devices for treatment of atrial fibrillation. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. To receive ‘‘Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation,’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301–847–8149 to receive a hard copy. Please use the document number 1708 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 11207 collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910–0120; the collections of information in 21 CFR parts 50 and 56 have been approved under OMB control number 0910–0130; and the collections of information under 21 CFR part 814 have been approved under OMB control number 0910–0231. V. Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// www.regulations.gov. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Dated: February 11, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–03487 Filed 2–14–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Transmissible Spongiform Encephalopathies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Transmissible Spongiform Encephalopathies Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on March 14, 2013, from 8 a.m. to 4 p.m. E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

[Federal Register Volume 78, Number 32 (Friday, February 15, 2013)]
[Notices]
[Page 11207]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03487]

[[Page 11207]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0395]

Clinical Study Designs for Surgical Ablation Devices for
Treatment of Atrial Fibrillation; Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Clinical Study Designs for
Surgical Ablation Devices for Treatment of Atrial Fibrillation.'' This
guidance provides FDA's recommendations on clinical trial designs for
surgical ablation devices intended for the treatment of atrial
fibrillation.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Clinical Study Designs for Surgical Ablation
Devices for Treatment of Atrial Fibrillation'' to the Division of Small
Manufacturers, International and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 301-847-8149. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Libet Garber, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1254, Silver Spring, MD 20993-0002, 301-796-6912.

SUPPLEMENTARY INFORMATION:

I. Background

Atrial fibrillation (AF) is a complex arrhythmia of the heart. This
guidance describes elements of suggested clinical study design for
surgical ablation devices used to treat patients with longstanding
persistent AF and patients with symptomatic paroxysmal AF, such as
inclusion and exclusion criteria and assessment of effectiveness, which
may differ for these patient populations. In the Federal Register of
September 14, 2009 (74 FR 46996), FDA announced the availability of the
draft guidance document. Interested persons were invited to comment by
December 14, 2009. Three sets of comments were received with
recommendations related to definitions and certain elements of the
recommended study design(s), such as study endpoints, endpoint
assessments, appropriate control groups, and followup of study
subjects. In response, FDA revised the guidance document to address the
comments and clarify our recommendations as appropriate. This guidance
supersedes the draft guidance entitled ``Clinical Study Designs for
Surgical Ablation Devices for Treatment of Atrial Fibrillation,'' dated
September 14, 2009.

II. Significance of Guidance

This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on clinical study designs for surgical
ablation devices for treatment of atrial fibrillation. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute and
regulations.

III. Electronic Access

Persons interested in obtaining a copy of the guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. To receive
``Clinical Study Designs for Surgical Ablation Devices for Treatment of
Atrial Fibrillation,'' you may either send an email request to
dsmica@fda.hhs.gov to receive an electronic copy of the document or
send a fax request to 301-847-8149 to receive a hard copy. Please use
the document number 1708 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
part 807, subpart E, have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR parts 50 and 56 have
been approved under OMB control number 0910-0130; and the collections
of information under 21 CFR part 814 have been approved under OMB
control number 0910-0231.

V. Comments

Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to https://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

Dated: February 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03487 Filed 2-14-13; 8:45 am]
BILLING CODE 4160-01-P

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